Greater Atlanta Integrative Pediatrics
This clinical research study evaluates the safety and preliminary effects of AdiaVita (umbilical cord blood-derived stem cells and exosomes) combined with glutathione versus glutathione alone in people aged 3 and older with Autism Spectrum Disorder (ASD). In this randomized, participant-blinded crossover trial of about 100 participants, one group receives three monthly AdiaVita IV infusions plus glutathione, while the control group gets placebo saline infusions with the same glutathione regimen; the primary outcome is improvement on Autism Treatment Evaluation Checklist (ATEC) scores, with full safety follow-up through 12 months and optional crossover to AdiaVita for eligible controls. The treatment is investigational and not FDA-approved for autism, with no guaranteed benefit and risks including infusion reactions; participants pay $12,000 for the initial schedule, and all data remains confidential.
The study evaluates the safety and preliminary effects of combining AdiaVita, an umbilical cord blood-derived stem cell and exosome product, with glutathione in individuals aged 3 years and older diagnosed with Autism Spectrum Disorder (ASD). Researchers will compare participants receiving AdiaVita plus glutathione against participants receiving glutathione alone using changes in Autism Treatment Evaluation Checklist (ATEC) scores as the primary outcome measure. The study is designed as a randomized, participant-blinded crossover trial with approximately 100 participants recruited primarily fr…
Inclusion Criteria: * Age 3 years and up * Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2 or its equivalent) * Parent/guardian willingness to consider experimental treatments and comply with study requirements * Ability to obtain required bloodwork * Ability to attend all scheduled visits Exclusion Criteria: * Severe allergies to study products * Significant uncontrolled medical conditions * Immunocompromised * Malignancy history * Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseli…
Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Initial Treatment Schedule)